Insertion handle for surgical implants

ABSTRACT

An insertion handle for medical implants includes a handle with an elongate shaft extending therefrom and connection means for the implant disposed at the end of the shaft opposite the handle. The connection means includes a pivotable attachment for the implant that is controlled remotely from the handle. Both angle of the implant with respect to the handle and shaft as well as the attachment may be separately controlled and adjusted. Remote angular adjustment facilitates insertion of implants in to small surgical sites because the orientation of the implant may be repeatedly, remotely adjusted as the implant is inserted. Connectors may also be provided at the engagement surface between the handle and implant in order to provide communication with the implant or surgical site. The connectors also may serve as torque bearing members to avoid the need for separate torque bearing means such as keyways and the like.

RELATED APPLICATION DATA

The present application is a continuation of U.S. patent applicationSer. No. 13/264,498, filed on Nov. 17, 2011, which is a national phaseentry under 35 U.S.C. § 371 of International Application No.PCT/US2010/31247 filed on Apr. 15, 2010, which claims priority fromProvisional Application No. 61/212,808, filed on Apr. 16, 2009, thedisclosures of which are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention generally relates to the field of surgical toolssuch as tools used in orthopedic surgical procedures. In particular,embodiments of the present invention are directed to an insertion handlefor implants such as spinal implants.

BACKGROUND

A variety of devices for holding, manipulating and inserting medicalimplants during surgical procedures are known in the art. As techniquesfor less-invasive surgeries are refined, surgical access openings aremade increasingly smaller in an attempt to reduce patient trauma andrecovery time.

In light of the developments in less-invasive surgeries, there is acontinuing need for such devices that provide for greater and moreprecise control over the manipulation and orientation of implants beinginserted.

SUMMARY OF THE DISCLOSURE

In one implementation, the present disclosure is directed to anapparatus for inserting a medical implant. The apparatus includes: ahandle; an outer shaft extending from the handle along a shaft axis; aninner control shaft extending through the outer shaft along the shaftaxis; an actuator disposed with the handle and cooperating with theinner control shaft to move the inner control shaft within the outershaft in response to user manipulation of the actuator; and pivotableconnection means disposed on the outer shaft opposite the handle andcooperating with the inner shaft to engage or release an implant, and toangularly position the implant with respect to the shaft axis inresponse to movement of the inner control shaft, the pivotableconnection means including user selectable lock means for selectivelylocking an implant engaged thereon at a fixed angle relative to theshaft axis.

In another implementation, the present disclosure is directed to anapparatus for inserting a medical implant. The apparatus includes: ahandle; an outer shaft extending from the handle along a shaft axis; arotatable inner shaft extending through the outer shaft along the shaftaxis; an actuation member disposed with the handle and cooperating withthe inner shaft to permit user rotation of the inner shaft; a distal endmember mounted on the outer shaft opposite the handle, the distal endmember having an annular wall defining an opening in a directiontransverse to shaft axis with an inner engagement surface, and defininga window opening through the annular wall substantially in line with theouter shaft; a pivot member disposed within the opening defined by theannular wall of the distal end member, the pivot member having an outerengagement surface facing at least a portion of the inner engagementsurface and being rotatable within the opening about an axis transverseto the shaft axis; and an attachment screw rotatably mounted in thepivot member and extending through the window opening along a screwaxis, the attachment screw operatively connected to the inner shaft topermit rotational drive of the attachment screw through variable anglesbetween the screw axis and shaft axis; wherein the annular wall isdeformable at least in part in response to a medical implant beingtightly threaded onto the attachment screw to force engagement betweenthe engagement surfaces to selectively lock the pivot member at a fixedangle with respect to the shaft axis.

In still another implementation, the present disclosure is directed to amethod for inserting a medical implant using an insertion handle. Themethod includes: attaching the medical implant to a distal end of theinsertion handle wherein a first angle is formed between an axis of theimplant and an axis of the insertion handle; locking the implant againstrotation at the first angle; inserting the implant at a surgical site toa first position; unlocking the implant to permit rotation; changing theangle between the implant axis and the handle axis to a second angle;locking the implant against rotation at the second angle; inserting theimplant to a final position; and detaching the insertion handle from theimplant.

BRIEF DESCRIPTION OF THE DRAWINGS

For the purpose of illustrating the invention, the drawings show aspectsof one or more embodiments of the invention. However, it should beunderstood that the present invention is not limited to the precisearrangements and instrumentalities shown in the drawings, wherein:

FIG. 1 is a perspective view of one embodiment of the present invention.

FIG. 2A is a side view of the embodiment shown in FIG. 1.

FIG. 2B is a cross-sectional view of the embodiment shown in FIG. 1taken through Line A-A.

FIGS. 2C-2E are detailed cross-sectional views of the pivoting headshown in FIG. 2B in various angular positions.

FIGS. 3A-3E illustrate an implantation sequence of top views of anembodiment of the present invention with an implant and a surgicaltreatment site shown.

FIG. 4 is perspective view of an alternative embodiment of the presentinvention shown with an implant attached.

FIG. 5A is a side view of yet another alternative embodiment of thepresent invention.

FIG. 5B is a cross-sectional view of the embodiment shown in FIG. 5Ataken through Line A-A.

FIG. 5C is a broken top view of the embodiment shown in FIG. 5A.

FIG. 5D is a broken cross-sectional view of the embodiment shown in FIG.5A taken through line A-A.

FIG. 6A is a side view of yet another alternative embodiment of thepresent invention.

FIG. 6B is a front end view of the embodiment shown in FIG. 6A.

FIG. 6C is a broken cross-sectional view of the embodiment shown in FIG.6B taken through line A-A.

FIG. 6D is a detailed cross-sectional view of the pivoting head shown inFIG. 6C.

FIG. 7 A is a perspective view of yet another embodiment of the presentinvention.

FIG. 7B is a side view of the embodiment shown in FIG. 7 A.

FIG. 7C is a cross-sectional view of the embodiment shown in FIG. 7Btaken through Line B-B.

FIG. 7D is a cross-sectional view of the embodiment shown in FIG. 7Btaken through Line C-C.

FIG. 8 is an enlarged side view of the attachment end of an insertionhandle according to an embodiment of the present invention.

FIG. 9A is a side view of the proximal end of yet another embodiment ofthe present invention.

FIG. 9B is a side cross-sectional view of the embodiment shown in FIG.9A.

FIG. 9C is an axial cross-sectional view of the embodiment shown in FIG.9A taken through line A-A.

FIG. 10 is an axial cross-sectional view of yet another embodiment ofthe present invention.

FIG. 11A is an end view of yet another embodiment of the presentinvention.

FIGS. 11B and 11C are side cross-sectional views of the embodiment shownin FIG. 11A taken through line A-A with the actuator lock in differentpositions.

FIG. 11D is a side cross-sectional view of the embodiment shown in FIG.11A taken through line B-B.

FIGS. 12A and 12B are side and top views respectively of yet anotherembodiment of the present invention.

FIG. 13A is a top view of yet another embodiment of the presentinvention.

FIG. 13B is a cross-sectional view looking in the superior direction ofthe embodiment shown in FIG. 13A.

FIG. 13C is a detailed cross-sectional view of the distal end of theembodiment shown in FIG. 13B.

FIG. 13D is a detailed cross-sectional view of the proximal end of theembodiment shown in FIG. 13B.

FIG. 14A is a top view of yet another embodiment of the presentinvention.

FIG. 14B is an enlarged section view of the embodiment in FIG. 14A atcircle B.

DETAILED DESCRIPTION

Embodiments of the present invention pertain to a surgical device whichis used to surgically place an implant into the desired location of thebody. More particularly, embodiments of the present invention aredesigned to allow placement of an implant into a position that isrotationally different than the position in which it is first insertedinto the body. Such rotationally variable placement is achieved inembodiments of the present invention while maintaining constantattachment to the implant to permit forcible manipulation thereof.

Turning now to FIG. 1, one embodiment of inserter 10 is shown, which iscomprised of a handle 12, a shaft 14 attached thereto, a distal endmember, formed for example, as a pivot cage 18 attached to the other endof the shaft 14, a pivot member or head 16 captured inside a transverseopening defined by the annular wall of the pivot cage 18 and anattachment screw 22 partially contained in the pivot head 16. Theattachment screw 22 protrudes from the distal end of the inserter 10from the pivot head 16 through the pivot cage 18 via the pivot cagewindow 20. At the proximal end of the handle is an attachment actuator24 which is rotationally coupled to the attachment screw 22 as will beshown herein.

As can be seen in FIGS. 2A-2E, the attachment actuator 24 is connectedto an attachment shaft 26 which passes through the inside of the handle12 and the shaft 14. The attachment shaft distal end 28 has a hexagonalsided ball end shaped to engage the attachment screw interface 30.Interface 30 may be a socket configured to receive ball shaped distalend 28, thus forming a universal joint. This engagement of theattachment shaft distal end 28 and the attachment screw interface 30enables rotational force applied by the user to the attachment actuator24 to be transferred through the attachment shaft 26 to the attachmentscrew 22. This rotational force turns the screw to engage a medicalimplant. In this embodiment, the engagement and tightening of themedical implant (as will be explained in more detail herein) bothattaches the implant to the inserter 10 and also rotationally locks thepivot head 16 to the pivot cage 18 fixing the angle between theinsertion handle 12 and the implant. This rotation is accomplished byproviding clearance for the attachment shaft 26 both by an attachmentshaft taper 34 and with a pivot head pocket 32. The geometry of thepivot head pocket 32, the attachment shaft taper 34 and the pivot cagewindow 20 allows the pivot head 16 and attachment screw 22 to rotatethrough a predetermined angle as shown in FIGS. 2C-2E. This angle can bedesigned as needed to allow for the appropriate amount of rotation ofthe implant relative to the inserter 10 as will be described in moredetail below.

FIGS. 3A-3E depict the inserter 10 being used to place an implant 36into an intervertebral space 50 in a patient's spine, and the use of oneembodiment of a user selectable lock means to position the implantangularly with respect to the inserter longitudinal axis to facilitateplacement. In FIG. 3A, implant 36 is attached to the inserter 10 via animplant interface 38 which conforms to the pivot cage 18. Implant 36 hasan elongated shape along implant axis 8. Implant axis 8 is oriented at apredetermined angle to screw axis 7 along attachment screw 22. Due tothe pivotability of pivot head 16, the angle between the implant axis 8and the longitudinal axis 5 of shaft 14 may be selected by the user asdescribed herein.

Rotation of the attachment actuator 24 threads the attachment screw 22through the implant interface 38 into the implant 36. The implant 36 isalso fixed at a predetermined angle relative to the inserter 10 byrotation of the attachment screw 22 into the implant until the implant36 is pressed against the implant interface 38 which in turn is pressedagainst the pivot cage 18 which in turn is compressed against the pivothead 16. Thus, in this embodiment the user selectable lock meanscomprises the annular walls of the pivot cage 18 being deformable atleast in part so that the inner surface of the annular wall can engageat least part of the outer surface of pivot head 16. In this manner, thecompressed assembly clamps the pivot head 16 and pivot cage 18 togetherand prevents rotation of the pivot head 16. It will be apparent to thoseschooled in the art that the implant interface 38 is not required toaccomplish the attachment of the inserter 10 to the implant 36, neitheris it required to accomplish the prevention of rotation of the pivothead 16. Alternate embodiments of the current invention are possiblewhich integrate the implant interface 38 as part of the pivot cage 18 oras part of the implant 36. The implant interface 38 is useful in thatdifferent implant interface 38 designs will enable the same inserter 10to be used on many different implants 36.

Returning to FIGS. 3A and 3B, the inserter 10 is used to guide theimplant 36 accurately and safely through a narrow surgical opening 44with a lateral side 45 and a medial side 47 created between an inferiorvertebra 40 by removing the superior facet and a superior vertebra 42 byremoving the inferior facet. The intervertebral space 50 is created byremoving a portion of the disc annulus 46 and disc nucleus 48. Asillustrated in FIG. 3A, the implant 36 is initially inserted along astraight insertion path (arrow) parallel to the medial side 47 and onthe longitudinal axis 5 of the handle into the disc and then further upagainst the inner wall of the annulus 46 as shown in FIG. 3B. At thisstage the implant axis 8 and the shaft axis 5 are at a first angle withrespect to each other. This is not an optimal position for the implant36. Rather there is a need to rotate the implant 36 to move it towardsthe center of the intervertebral space 50. This rotation may beaccomplished in steps in this embodiment by first pivoting the inserter10 towards the lateral side 45 of the surgical opening 44 and next byrotating the attachment actuator 24 (curved arrow) to rotate theattachment screw 22 and loosen the compression between the implant 36and the pivot head 16. This release of compression allows the implant36, attachment screw 22, and pivot head 16 to rotate when additionalforward movement (hollow arrow) presses the implant 36 against theannulus 46 as shown in FIG. 3C. At the same time the insertion handleshaft 14 pivots back towards the medial side 47 of the surgical opening44 to form a second angle between the implant axis 8 and the shaft axis5. The attachment actuator 24 can then be rotated (curved arrow) back tocompress the implant 36 against the implant interface 38 and lock thepivot head 16 in the pivot cage 18 to allow the inserter 10 to axiallyand pivotally advance the rotational locked implant 36.

The process of locking the rotation, advancing and pivoting the inserter10 and implant 36 as a unit, unlocking the attachment actuator 24 andpivoting the pivot cage 18 and implant 36, and relocking the rotation isrepeated as necessary until the implant 36 is placed at the desiredlocation as shown in FIG. 3D. Through this process the implant axis 8 ispositioned at least at a third angle with respect to the shaft axis 5.Embodiments of the present invention thus allow placement of an implant36, with a rotational orientation that is different from the originalinsertion orientation, into a surgical site through a much smallersurgical opening 44 with much smaller pivoting angle of the inserter 10than otherwise possible.

After placement of implant 36 at a desired location, the attachmentactuator 24 is rotated (curved arrow) until the attachment screw 22 iscompletely removed from the implant. Then the inserter 10 and implantinterface 38 can be removed (hollow arrow) from the surgical siteleaving the implant 36 in place as shown in FIG. 3E. This illustratesjust one of the many possible surgical sites were the inserter 10 can beused to advance and rotate a medical implant to a desired location inthe body.

Turning now to FIG. 4, an alternative embodiment of the presentinvention is shown. In this embodiment, inserter 10 includes accesstubing 112, which are shown parallel to the shaft 14. Access tubing 112connects the implant interface 38 to the handle 12. The access tubing112 can be used for a number of functions such as delivering fluids orother materials through the handle 12 and implant interface 38 to theimplant 36, removing materials from the implant 36, containing and/orguiding an actuator such as a tension line or rotator drive, or guidinglight or electrical signals. Materials that can be delivered through theaccess tubing 112 include but are not limited to sterile saline, bonegraft, bone morphogenic proteins, cement, medication, etc. It will beapparent to those skilled in the arts that the access tubing 112 can bedirected inside the shaft 14 rather than external to it as shown in thisfigure.

FIGS. 5A-5D depict another embodiment of the present invention. In thisembodiment, inserter 210 separates the implant 36 attachment functionfrom the rotation function. There is both an attachment actuator 24 anda separate user selectable pivot lock actuator 212 in the handle 12. Theattachment actuator 24 is connected to the attachment shaft 26, whichwhen rotated rotates the attachment screw 22 to connect and disconnectto an implant (not shown). The pivot lock actuator 212 is attached to apivot lock transfer plate 220, which in turn is attached to a pivot lockshaft 214. The pivot lock shaft 214 rides between the shaft 14 and theattachment shaft 26. When the pivot lock actuator 212 is rotated in onedirection it advances forward on the threads of the pivot lock adjuster218, which advances the pivot lock shaft 214 into the pivot lock 216,which is contained in the pivot cage 18. The pivot lock 216 has pivotlock engagement faces 217, which are configured to engage pivot headengagement faces 219 on the pivot head 16. When these faces engage, thepivot head 16 is locked rotationally with the pivot cage 18. When thepivot lock actuator 212 is rotated in the other direction it retractsbackwards on the threads of the pivot lock adjuster 218. A pivot lockrelease actuator 226, which may be formed as a biasing element such as acoil spring, then retracts the pivot lock transfer plate 220 and theattached pivot lock shaft 214. This removes pressure on the pivot lock216 and allows the pivot head 16 to rotate relative to the pivot cage18. In this manner the inserter 210 allows the user to independentlyactuate the pivot locking and implant attachment functions. It will beapparent to those skilled in the art that this separation of functionscan be useful to the surgeon who is using the inserter 210 to place animplant precisely in a patient's body.

The inserter 210 may also include pivot lock adjustment anchors 222which lock the pivot lock adjuster 218 to the handle 12, and handle capanchors 234, which attach a handle cap 232 to the handle 12. The handlecap 232 is useful in providing a surface for the surgeon to hammeragainst to force the implant 36 into a confined intervertebral space 50.The pivot lock adjuster 218 with its threads can be used to adjust therelative location of the advancement and retraction of the pivot lockactuator 212 and in turn the pivot lock transfer plate 220, pivot lockshaft 214, and pivot lock 216. This allows for adjustment of the lockingmovement and therefore the locking force between the pivot lock 216 andthe pivot head 16. After this adjustment is made, the pivot lockadjuster anchors 222 fix the pivot lock adjuster 218 to the handle 12and maintain this locking movement. It will be apparent to those skilledin the art that there are many other mechanisms possible to provide forthe adjustment of the locking movement of the inserter 210 withoutdeparting from the present invention and this mechanism is provided asbut one example.

There are also many ways to separate the attachment and rotationfunctions in embodiments of the present invention to provide separateuser selectable lock means. Another such alternative embodiment is shownin the inserter 310 depicted in FIGS. 6A-6D. In this embodiment thepivot lock shaft 214 is connected to a pivot lock shaft pin 314, whichis connected to the pivot cage 18. The pivot cage 18 has a pivot cageslot 312 proximal of the pivot lock shaft pin 314. In this embodimentthe pivot lock shaft 214 is retracted via the pivot lock actuator 212 topull on the pivot lock shaft pin 314, which reduces the pivot cage slot312 and compresses the pivot cage 18 around the pivot head 16 locking itrotationally. This method of tensioning a portion of the pivot cage 18to increase the force between the pivot cage 18 and the pivot head 16and lock the pivot head 16 rotational is but one alternative. Forexample, in another alternative, the pivot cage 18 could also betensioned radially to compress it around the pivot head 16 and lock thepivot head 16 rotationally to the pivot cage 18.

In addition to the alternative embodiments described above, FIGS. 7 A-7Dshow yet another alternative embodiment of the present inventionincluding inserter 410, which can be attached to and rotate an implant36. The shaft 14 of inserter 410 is connected from the handle 12 to anattachment grip cage 418. At least two attachment grips 422 exit thedistal end of the attachment grip base 418 and are configured to rotatetowards each other and grab an implant (not shown). The attachment grips422 are connected by an attachment grip pivot 424, which is contained inthe attachment grip base 418. The attachment pivot 424 is also confinedby a tensioning slot 425 in the attachment grip pivot tensioner 426.Rotation of the attachment actuator 24 in one direction tensions theattachment shaft 26 which retracts the attachment grip pivot tensioner426. This action pulls the attachment grip pivot 424 further into theattachment grip cage 418 and up against the anchor pocket 428 preventingthe attachment grip pivot 424 from translating in the tensioning slot425. A slight rotation of the attachment actuator 24 in the otherdirection allows the attachment grip pivot 424 to move away from theanchor pocket 428, which in turn allows the attachment grip pivot 424 totranslate in the tensioning slot 425. The translation of the attachmentgrip pivot 424 in the tensioning slot 425 results in the pivoting of theattachment grips 422 relative to the attachment grip cage. This enablesimplant 36 rotation. Further rotation of the attachment actuator 24 inthe other direction moves attachment grip pivot 424 and the attachmentgrips 422 out of the front of the attachment grip cage 418 allowing theattachment grips 422 to separate and release the implant 36. In thismanner the attachment actuator 24 can be used to control both implantattachment/release and implant rotation relative to the inserter 410.

In previous embodiments the pivot lock 216 included engagement faces 217configured to engage engagement faces 219 on the pivot head 16 and lockit rotationally. In an alternative embodiment, shown in FIG. 8, theengagement faces 217 on the pivot lock 216 are configured to createfriction against the pivot head 16 to lock it rotationally. Theengagement faces 217 are also configured to allow fluid to flow betweenthe pivot lock 216 and the pivot head 16. One way to accomplish this isto provide squared off teeth on one of the opposed faces as shown. Thisis advantageous in that the engagement faces 217 provide for ease ofcleaning of the inserter 10 between uses. Furthermore, engagement faces215 can be provided on the pivot head to engage the pivot cage 218 andto create both friction and ease of cleaning between the pivot head 16and the pivot cage 18.

Use of the inserter 10 to place an implant 36 into an intervertebralspace 50 can include placing many loads and moments on the distal end ofthe inserter 10. Those loads and moments placed on the attachmentactuator 24 can cause undesired rotation of the attachment actuator.Axial impact forces on the order of 55 lbs or more may be placed on thedistal end of the inserter 10. Torques may be placed about any axis ofrotation relative to the inserter shaft 14 ranging from 20 to over 100inch pounds. Turning now to FIG. 9A-9C, another alternative embodimentof the current invention is depicted, which includes an actuator lock240. The actuator lock 240 is mounted on the handle 12 by means of apivot pin 254 (see FIG. 9C). The proximal end of the actuator lock 240extends away from the handle 12 and the distal end 251 extends into thehandle 12. The distal end 251 has a stop face 252, which is configuredto engage a ratcheted surface 250 of the attachment actuator 24. Anengagement spring 256 biases the stop face 252 against the ratchetedsurface 250 and prevents the attachment actuator 24 from rotating in adirection that loosens the attachment shaft 26. Depressing the proximalend of the actuator lock 240 towards the handle 12 pivots the actuatorlock 240 about the pivot pin 254 and disengages the stop face 252 fromthe ratcheted surface 250 allowing the attachment actuator to freelyrotate. In the embodiment shown, the ratcheted surface 250 is biasedrelative to the stop face 252 to allow rotation of the attachmentactuator 24 in the tightening direction even without depressing theproximal end of the actuator lock 240 towards the handle 12. Depressingof the actuator lock 240 is only needed to allow the attachment actuator24 to loosen. It is apparent to those skilled in the art that theratcheted surface 250 can also be configured to lock the attachmentactuator 24 in both the loosening and the tightening directions unlessthe actuator lock 240 is depressed. Also shown in these figures is acannulated connecting bolt 242, which connects the attachment actuator24 to the handle 12. The inclusion of bearing 244 facilitates rotationin this connection. Axial force on the handle cap 232, which is oftenneeded to direct the implant 36 into the intervertebral space 50 isaccommodated by the beveled washer 248 located between the cannulatedconnecting bolt 242 and the bearing 244. Rotational force is transferredbetween the attachment actuator 24 and the attachment shaft 26 by theactuator connecting screw 246.

In addition to the actuator lock 240 described above, embodiments of thepresent invention can also include a pivot lock 340 as shown in FIG. 10.The pivot lock 340 also has a proximal end 341 and a distal end 351 andpivots about a pivot lock pin 354. The distal end 351 has a pivot stopface 352 configured to engage a pivot ratcheted surface 350 located on apivot lock actuator 212. A pivot lock spring 356 is positioned betweenthe handle 12 and the proximal end 341 of the pivot lock 340 and biasesthe pivot stop face 352 into the pivot ratcheted surface 350 therebypreventing rotation of the pivot lock actuator 212. Depressing theproximal end 341 of the pivot lock 340 rotates the pivot lock 340 aboutthe pivot lock pin 354 and disengages the pivot stop face 352 from thepivot ratcheting surface 350 allowing rotation of the pivot lockactuator 212. It will be apparent to those skilled in the art thatinsertion handles in accordance with embodiments of the presentinvention may include either or both of the pivot lock 340 and theactuator lock 240.

FIGS. 11A-D depict another alternative embodiment of the actuator lock240, wherein the attachment shaft 26 is removed as shown in FIGS. 11B, Cand D for clarity. In this embodiment the actuator lock 240 is mountedin through hole 243 that passes through the handle 12. The actuator lock240 contains a cam slot 260, which is configured to engage a transferpin 262 mounted on the locking carriage 264. The locking carriage 264 iscontained in the handle 12 between the handle cap 232 and the attachmentactuator 24. The locking carriage 264 contains the stop face 252, whichis configured to be received by one of several stop holes 258 located onthe attachment actuator 24. Depressing the actuator lock 240 (arrow inFIG. 11C) causes the cam slot 260 to force the transfer pin 262distally. This action in turn translates the locking carriage 264 andthe stop face 252 distally such that the stop face 252 engages one ofthe stop holes 258 and prevents rotation of the attachment actuator 24.Pressing the actuator lock 240 in the other direction will disengage thestop face 252 from the stop hole 258 and allow rotation of theattachment actuator 24. This alternative locking embodiment can be usedfor preventing movement of either the attachment actuator 24 or thepivot lock actuator 212. It will be apparent to those skilled in the artthat any manner of actuator locks can be used to prevent movement ofeither or both of the attachment actuator 24 or the pivot lockingactuator 212 without departing from the present invention.

FIGS. 12A and 12B depict another embodiment of the present inventionthat includes additional features. As was described above for theembodiment described in connection with FIG. 4, the inserter 10 caninclude access tubing 112. The access tubing 112 can interface with animplant 36 by means of implant connectors 282 located at the distal endof the inserter 10. Connectors 282 may extend through and from implantinterface 38. The connectors can facilitate any manner of interactionwith the implant including but not limited to electrical current,optical information, rotational power, fluid pressure, materialtransport. This interaction can flow one way or the other or both. Theinserter 10 can also include an external connector 280 to further allowinteraction through the inserter 10 with the implant 36 by means of theimplant connectors 282. The external connector 280 can be configured forany manner of interaction between the inserter 10 and other equipmentrequired for surgery including suction, aspiration, irrigation,injection, illumination, coagulation or other such equipment that iscommonly used in surgery.

In one exemplary embodiment, the external connector 280 is configured toconnect with a saline filled syringe which is used to supply pressurizedsaline to the implant 36 through the implant connectors 282 in order toexpand the implant to a larger size after being implanted through aminimally invasive surgical opening. One example of such an expandableimplant is shown and described in co-pending U.S. patent applicationSer. No. 11/535,432 filed Sep. 26, 2006, entitled “Selectively ExpandingSpine Cage, Hydraulically Controllable in Three Dimensions for EnhancedSpinal Infusion,” which is incorporated by reference herein in itsentirety. In another exemplary embodiment, the external connector 280 isconfigured to supply bone graft and or bone morphogenic protein to theimplant to facilitate bony fusion. Although the embodiment shown inFIGS. 12A and B includes a single external connector 280 leading to twoimplant connectors 282, any number of either of these connectors arepossible without departing from the scope of the current invention.

In addition to providing an interaction or exchange function between theimplant 36 and the inserter 10 as described above, the implantconnectors 282 also provide a torque transfer function. As the implantconnectors 282 are spaced from the attachment screw 22, the implantconnectors 282 provide resistance to any relative rotation between theimplant 36 and the implant interface 38. This is particularly importantas the attachment screw 22 engages the implant 36 through rotationalmovement. The one or more implant connectors 282 help to prevent anyundesired rotation and subsequent loosening of the implant 36 relativeto the inserter 10. For this purpose, implant connectors 282 should havesufficient strength to resist torque in a given application. Persons ofordinary skill in the art may design the size and shape of the implantconnectors based on the teachings contained herein in order to withstandanticipated torque for any appropriate medical implant and its intendedapplication. For example, implant connectors 282 can be fabricated from304 stainless steel and extend 0.5 inches from the implant interface 38at a location 0.25 inches from the central axis of the implant interface38 such that they are rigid enough to resist the 100 inch pounds ofrotation force placed on the implant 36. Utilization of the implantconnectors for this purpose obviates the need for separate torquebearing structures such as keyways and the like, thus simplifying theengagement surfaces between the implant and inserter.

A detailed description has been given of the pivoting function inembodiments of the present invention and possible variations thereof. Inmany surgical procedures, due to the minimally invasive nature and/ordue to the proximal anatomy, the physician may not be able to clearlysee in which rotational position of the pivot head 16 is set. Ittherefore may be desirable in some embodiments to provide a positionindicator 370 to indicate rotational position information as shown inFIGS. 13A-13D (attachment shaft 26 and pivot lock shaft 214 are removedfor further clarity in FIGS. 13B and 13D). The position indicator 370includes a position pivot 376, a position actuator 372, a position lever374, a position cover 383, and a position marker 379. The distal end ofthe position actuator 372 has a bend 373 which is configured to bereceived by a distal pocket 375 in the pivot cage 16. The positionactuator 372 extends from the pivot cage 16 back through the shaft 14between the shaft 14 and the pivot lock shaft 214. Inside the handle 12,the position actuator 372 has a proximal bend 381, which is configuredto be received by a proximal pocket 380 in the position lever 374.Rotation of the pivot cage 16 creates translation of the positionactuator 372, which results in rotation of the position lever 374 aboutthe position pivot 376. The rotating position lever 374 rotates theposition marker 379, which can be viewed through different positionopenings 371 in the position cover 383. The position cover 383 can alsohave position icons 385, which may correspond to different rotationalpositions of the distal end of the inserter 10 to provide additionalvisual information that relates the position marker's 379 location inthe position opening 371 to a distal end configuration. In addition theposition pivot 376 can have a position pointer 377 on its exposed endwhich also rotates with the pivot 376 to provide additional visualrotation information. Alternatively, the position indicator may be usedto position the angle of the pivot head 16 by user manipulation of amember extending outward from position lever 374.

Although embodiments of the present invention described above includecertain functions such as the exchange and interface functions with theimplant, alternative embodiments of the present invention may providethose functions with a separate device. For example, turning to FIGS.14A and 14B, an embodiment of an inserter 10 is shown that interfaceswith a tubing set 290 both of which are configured to interface with animplant 36. The distal end of the tubing set 290 includes an implantinterface 38 with implant connectors 282 to interface with the implant36. The tubing set 290 also includes access tubing 112 and shaft clips395, which are configured to constrain the access tubing 112 to theinserter shaft 14. The tubing set 290 further may include at least oneexternal connector 280 at the proximal end, which is configured asdescribed above to interface with other surgical equipment. In addition,the tubing set 290 may include a diverter valve 284. The diverter valve284 is configured to open or close the connection between the externalconnector 280 and one or more access tubing 112. In the embodiment shownin FIG. 14A, the diverter valve 284 is configured to either provideopenings to both access tubing 112 simultaneously, to close the openingto one or the other access tubing 112, or to close the openings to bothaccess tubing 112 simultaneously. Providing a kit that contains thecombination of the inserter 10 and various configurations of accesstubing 290 enables more flexibility to the physician to use the currentinvention to insert and manipulate a wide variety of implants.

As better seen in FIG. 14B, connectors 282 are formed as separatemembers inserted and secured in implant interface 38. Each connector 282includes a passage 281 that communicates with tubing 112. Tubing 112enters the back of interface 36 through openings 287 in which theconnectors 282 are mounted. 0-ring type seals 283 are provided to form atight seal with corresponding passages 285 in implant 36. Centralpassageway 288 is provided for engagement screw 22 to freely passthrough interface 38 for engagement with the implant. The mating face ofimplant 36 is also provided with a threaded hole 286 to receiveattachment screw 22.

The present invention can be fabricated from numerous materials know tothose skilled in the art. For example the handle 12, shaft 14, pivotcage 18 and pivot head 26 can all be made from any one of the number ofbiocompatible metals such as titanium, titanium alloy, or stainlesssteels including 303 and 304. The attachment actuator 24, externalconnector 280 implant interface 38 can all be made of a polymer such aspolyacetal (e.g., Delrin®) or polyether ether keton (PEEK). The entireinserter 10 can be made of inexpensive materials so that it is singleuse and disposable or of more durable materials so that it can becleaned and reused several or even hundreds of times.

Terms such as “element,” “member,” “device,” “section,” “portion,”“step,” “means” and words of similar import when used in the followingclaims shall not be construed as invoking the provisions of 35 U.S.C. §112(6) unless the following claims expressly use the term “means”followed by a particular function without specific structure orexpressly use the term “step” followed by a particular function withoutspecific action. All patents and patent applications referred to aboveare hereby incorporated by reference in their entirety.

Exemplary embodiments have been disclosed above and illustrated in theaccompanying drawings. It will be understood by those skilled in the artthat various changes, omissions and additions may be made to that whichis specifically disclosed herein without departing from the spirit andscope of the present invention.

The invention claimed is:
 1. An instrument for inserting a medicalimplant, comprising: a handle; an outer shaft extending from the handlealong a shaft axis; an inner shaft extending at least partially throughthe outer shaft; an actuator coupled to the handle and configured tocause movement of the inner shaft within the outer shaft; and a cagemounted on the outer shaft opposite the handle and having an annularwall, a window defined in the annular wall and being aligned with theouter shaft; a pivot head disposed within the cage and being rotatablewithin the cage about an axis transverse to the shaft axis; anattachment screw for engagement with a medical implant, the attachmentscrew being rotatably disposed within the pivot head and extending alonga screw axis through the window of the annular wall, the attachmentscrew rotatably coupled with the inner shaft to permit rotational driveof the attachment screw through variable angles between the screw axisand shaft axis; and an implant interface disposed on the cage oppositethe outer shaft, the attachment screw configured to extend through theimplant interface.
 2. The instrument of claim 1, further comprising auser selectable lock apparatus including: a pivot lock shaft extendingbetween the handle and the cage; a locking actuator coupled to thehandle and the pivot lock shaft and configured to cause axial movementof the pivot lock shaft; and a lock member disposed within the cage,such that axial movement of the pivot lock shaft in a direction towardsthe cage forces the lock member to bear against the pivot head tosubstantially prevent rotation of the pivot head within the cage.
 3. Theinstrument of claim 2, wherein the user selectable lock apparatusfurther comprises a threaded member disposed within the handle and thelocking actuator is a collar having internal threads configured toengage the threaded member, such that rotation of the locking actuatorcauses axial movement of the pivot lock shaft.
 4. The instrument ofclaim 1, wherein the implant interface and the pivot head are formed asa monolithic member.
 5. The instrument of claim 1, wherein the implantinterface is a separate member from the pivot head.
 6. The instrument ofclaim 1, wherein the implant interface further comprises an implantconnector and a communication port, the implant connector beingconfigured to engage a port on a medical implant.
 7. The instrument ofclaim 6, further comprising a tube communicating with the communicationport.
 8. An instrument for inserting a medical implant, comprising: ahandle; an outer shaft extending from the handle along a shaft axis; arotatable inner shaft extending at least partially through the outershaft; an actuator coupled to the handle and the inner shaft, theactuator configured to cause rotation of the inner shaft; an annularwall mounted on the outer shaft opposite the handle, the annular walldefining a window and an opening with an inner engagement surface; apivot member disposed within the opening, having an outer engagementsurface facing at least a portion of the inner engagement surface, andbeing rotatable within the opening about an axis transverse to the shaftaxis; and an attachment screw for engagement with a medical implant, theattachment screw being rotatably disposed within the pivot member andextending along a screw axis through the window, the attachment screwrotatably coupled with the inner shaft to permit rotational drive of theattachment screw through variable angles between the screw axis andshaft axis; wherein, when the inner engagement surface and the outerengagement surface are engaged with each other, rotation of the pivotmember within the opening is substantially prevented.
 9. The instrumentof claim 8, wherein the engagement surfaces include teeth.
 10. Theinstrument of claim 8, further comprising an angle indicator coupled tothe pivot member to indicate a value of an angle between the screw axisand shaft axis.
 11. The instrument of claim 10, wherein the angleindicator comprises: a position indicator pivotally coupled to thehandle; and at least one linkage member having a proximal end coupled tothe position indicator and a distal end coupled to the pivot member. 12.The instrument of claim 8, further comprising an implant interfacedefining a central passageway, the implant interface disposed on theannular wall opposite the outer shaft, the attachment screw configuredto extend through the central passageway.
 13. The instrument of claim12, wherein the implant interface and the pivot member are formed as amonolithic member.
 14. The instrument of claim 12, wherein the implantinterface further comprises an implant connector and a supply port, theimplant connector communicating with the supply port, being spaced fromthe attachment screw, and being configured to engage a port on a medicalimplant.
 15. An instrument for inserting a medical implant, comprising:a handle; an outer shaft extending from the handle along a shaft axis;an inner shaft extending at least partially through the outer shaft; anactuator coupled to the handle and the inner shaft and configured tocause movement of the inner shaft within the outer shaft; and a cagemounted on the outer shaft opposite the handle and having an annularwall, a window defined in the annular wall and being aligned with theouter shaft; a pivot head disposed within the cage and being rotatablewithin the cage about an axis transverse to the shaft axis; and anattachment screw for engagement with a medical implant, the attachmentscrew being rotatably disposed within the pivot head and extending alonga screw axis through the window, the attachment screw rotatably coupledwith the inner shaft to permit rotational drive of the attachment screwthrough variable angles between the screw axis and shaft axis; an accesstube adapted to provide fluid communication with a medical implant; andan external connector coupled to the access tube and configured toconnect to external surgical equipment.
 16. The instrument of claim 15,further comprising a diverter valve configured to open or close aconnection between the external connector and the access tube.
 17. Theinstrument of claim 16, wherein the access tube is a plurality of accesstubes and wherein the diverter valve is configured to open or close theconnection between the external connector and the plurality of accesstubes.
 18. The instrument of claim 16, wherein the diverter valve iscoupled to the handle and the access tube extends outside the outershaft from the handle to an implant interface.
 19. The instrument ofclaim 15, further comprising a shaft clip coupling the access tube tothe outer shaft.
 20. The instrument of claim 15, further comprising amedical implant coupled to the attachment screw and in fluidcommunication with the access tube.